Fall Risk Reduction in Multiple Sclerosis (FIRMS)

Multiple Sclerosis Clinical Trial

— FIRMS  

Official title:

Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02314585
• Other study ID #: 15053
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2014
• Last updated: August 25, 2015
• Start date: December 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2015
• Source: University of Illinois at Urbana-Champaign
• Contact: Jen Wajda, BS
• Phone: 217-300-1696
• Email: jwajda[@]illinois.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study looks to see the effects of a home based exercise program on falls in people with MS.

Description:

The purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with MS; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria involve having an established definite diagnosis of MS

• Ability to walk 25 feet with or without aid

• Relapse free in the last 30 days

• Being = 50 years of age

• Having fallen at least once in the past year

• Physician approval to engage in light physical activity

• Willingness and ability to attend the training sessions and testing sessions.

Exclusion Criteria:

• We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.

• During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.

• Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Exercise
Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.
• Education
Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.

Locations

Country	Name	City	State
United States	Motor control research lab	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chagne in Fall Risk	The primary outcome measure of this investigation is physiological fall risk. Physiological fall risk will be determined by the short form of the physiological profile assessment (PPA). The PPA is a validated tool to assess physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function. It is predictive of future fall risk in persons with MS. The PPA provides a fall risk score that is based on the quantification of key physiological markers (e.g. vision, leg strength, proprioception, balance, cognition, etc) and comparison of those markers to age and gender matched normative data. The PPA provides a therapeutically relevant prognostic predictor of falls and this makes it an ideal outcome measure of investigations evaluating fall prevention strategies.	1 year	No
Secondary	Identification of Fall Risk Factors	The secondary outcome of fall incidence will be monitored prospectively for 6 months prior to and immediately following the 24 week intervention period via a fall diary A fall will be defined as an event where an individual unintentionally comes to the ground. Participants will receive a biweekly phone call and weekly text to inquire if they have suffered a fall and to remind them to complete the diary. If a fall is reported details of falls, information about injury, and other pertinent information will be attained. The fall diary will be contained in a brightly labeled binder and participants will be asked to mark if they have or have not fallen on a given day. At the end of each month participants will mail the dairy back in a preaddressed prepaid envelope to the research lab. The fall calls/diary will allow for the determination of number of falls, and fall rate per person year.	1 year	No